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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, urine flow rate measuring, non-electrical, disposable
Regulation Description Urine flow or volume measuring system.
Product CodeFFG
Regulation Number 876.1800
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No flow 37
Break 23
Device operates differently than expected 20
Leak 16
Occlusion within device 16
Defective item 11
Infusion or flow issue 11
Fluid leak 10
Restricted flowrate 8
Device damaged prior to use 7
Foreign material present in device 6
Improper flow or infusion 6
Sediment, precipitate or deposit in device or device ingredient 5
Fracture 5
Detachment of device component 5
Crack 5
Blockage within device or device component 4
Improper device output 4
Connection issue 3
Defective component 3
Product quality issue 3
Disconnection 3
Measurement system incompatibility 3
Delivered as unsterile product 2
Material separation 2
Use of Device Issue 2
Insufficient flow or underinfusion 2
Component missing 2
Detachment of device or device component 2
Device packaging compromised 2
Difficult to open or close 1
Device Contamination with biological material 1
Device disinfection or sterilization issue 1
Out-of-box failure 1
Obstruction within device 1
Unsealed device packaging 1
Material fragmentation 1
Kinked 1
Filling problem 1
Biofilm coating in device 1
Decoupling 1
Difficult to deploy 1
Failure to deploy 1
Item contaminated during manufacturing or shipping 1
Material integrity issue 1
Total Device Problems 243

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